On Apr. 21–24, the United States Pharmacopeial Convention (USP) held its convention in Washington, DC. This gathering of pharmacopeial
minds occurs once every five years and the outcome sets the direction and course of USP for the next five-year revision cycle
(July 1, 2010 to June 30, 2015).
Susan J. Schniepp
Before discussing some of the significant happenings that took place at this convention, it's worth recapping some facts about
USP. The independent, standard-setting organization was founded in 1820, long before the pharmaceutical industry came into
existence. At that time, pharmacists were essentially the drug manufacturers of their time. Still today, many USP convention
members are from the pharmacy community. Other members represent: US colleges and schools of medicine and pharmacy; state
medical societies and pharmacy associations; national and state professional and scientific organizations; governmental bodies;
health science and other foreign organizations and pharmacopeias; consumer organizations and individuals representing public
interests; and manufacturers, trade, and affiliated associations.
These member organizations name individuals to represent their specific interests at the convention. Delegates are responsible
for voting on changes to USP's constitution and bylaws, voting on nominees to the Board of Trustees, voting on nominees to
chair the USP expert committees, and debating and voting on resolutions. Of these responsibilities, the two that have the
greatest significance to industry are electing the committee chairs—who then set the standards of the USP–National Formulary (NF)—and voting on proposed resolutions, which define USP's strategic direction.
Chairs and committees
For the 2010-2015 revision-cycle, USP cut in half its number of committees from 40 to 20. Forty individuals were slated to
run for chairmanships, two for each available position. Of the 40 nominees, only 13 were from industry. In three instances,
the two candidates running for the same position were both from industry.
These numbers seem a little low for industry, considering that industry is the major contributor and user of the USP–NF. Industry experts understand what elements are required of a method to optimize analysis and instill confidence that the
pharmaceutical material—whether it is the drug substance, excipient, or dosage form—meets the necessary standards of identity,
strength, potency, and purity. It is the industry experts who practice the performance of these methods on a daily basis and
can understand when a method may not be optimal or suitable for inclusion in the pharmacopeia.
There were nine resolutions proposed for the 2010 Convention—all were adopted. Three were of particular interest to the pharmaceutical
industry as outlined herein. The first resolution calls on USP to strengthen its core compendial activities, working collaboratively
with industry, regulators,and stakeholders to ensure relevant, timely, and accurate public standards.
This should be USP's foremost activity and focus. The recent recall activities of USP 33–NF 28, along with other issues (e.g., monograph redesign project, the confusing implementation of residual-solvents testing,
the number of Errata in the Pharmacopeial Forum) have left industry with a sense that USP is losing touch of its main objective and responsibility to the US pharmaceutical
and medical community. The industry relies on USP to provide timely, accurate, and reliable standards. The specifications,
methods, and general test procedures published in USP are used by industry to test and release product that is suitable for
patient use. During the last five-year cycle, USP expanded operations to India and China and focused a considerable amount
of effort on international activities. This growth appears to have stretched USP's resources, which may have potentially contributed
to the unprecedented recall of the USP–NF. For USP to regain industry's confidence, the organization must ensure it has the proper amount of resources devoted to monograph
Second, a resolution on strengthening USP's relationship with the US Food and Drug Administration (Resolution 3) resolves
to have USP work more with the agency and other public and private stakeholders to explore mechanisms that would enable USP
to provide and maintain up-to-date national standards for legally marketed drugs and excipients in the United States.
Overall, industry seems to supports this resolution and believes it is critical for USP and FDA to work together. However,
such a partnership needs to consider the effect of their work on industry as it develops. FDA Commissioner Margaret Hamburg
spoke at the convention. She indicated that FDA and USP will be working together to identify materials that should have additional
tests to prevent adulteration with the intent of adding these mandatory tests to monographs. It is not readily apparent how
adding tests to monographs will actually prevent adulteration. By the time the adulteration is discovered and the potential
monograph test is discussed, adopted, and implemented the adulterators have gone on to different adulterants. The best way
to stop the adulteration is to the focus on supply-chain knowledge, supplier qualification, and supplier auditing. These activities
offer more security regarding the quality of material than does performing an additional monograph test on incoming material